Vanda Pharmaceuticals Inc. (VANDA) has announced encouraging topline data from its randomised controlled study evaluating Tradipitant in preventing nausea and vomiting caused by GLP-1 receptor agonist Wegovy in overweight and obese adults.
In this exploratory, randomized, double-blind, placebo-controlled study, 116 overweight or obese adults without prior GLP-1 experience were pretreated with tradipitant 85 mg twice daily or placebo for one week, followed by continued treatment for another week post-dosing.
Participants then received a 1mg injection of Wegovy, a dose typically reached after nine weeks of titration.
Results from the study showed that the trial met its primary endpoint, with 29.3% of participants treated with tradipitant experiencing vomiting, compared with 58.6% on placebo, representing a 50% relative reduction. The trial also achieved its key secondary endpoint, with 22.4% of tradipitant-treated participants experiencing both vomiting and significant nausea, versus 48.3% on placebo.
Safety remained consistent with prior studies, with no new adverse signals reported.
GLP-1-induced nausea and vomiting represent a significant barrier to adherence in obesity management, with real-world discontinuation rates reaching 30-50%. The study results suggest tradipitant may help reduce these side effects.
Tradipitant, originally licensed from Eli Lilly, is currently under development for multiple indications, including gastroparesis, GLP-1-induced nausea and vomiting, and motion sickness. It is also under review by the U.S. Food and Drug Administration (FDA) for motion sickness with a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025.
Looking ahead, Vanda plans to initiate a Phase 3 program in the first half of 2026 to evaluate tradipitant as a key adjunct to improve outcomes in GLP-1 agonist treatments.
VANDA has traded in the range of $3.81 to $5.70 over the past year. The stock closed yesterday's trading at $4.40, up 1.15%.
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